BETAXOLOL 0.5% EYE DROPS
Betaxolol 5.0 mg/ml (as betaxolol hydrochloride 5.6 mg/ml)
Please read this leaflet carefully before you start to take your medicine. Keep this leaflet. You may need to read it again. If you have any further questions, please ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
The medicine will be called Betaxolol in this leaflet.
In this leaflet:
1. What Betaxolol is and what is it used for
2. Before you use Betaxolol
3. How to use Betaxolol
4. Possible side effects
5. How to store Betaxolol
6. Further information
What Betaxolol Is And What Is It Used For
The active ingredient betaxolol belongs to a group of medicines called beta-blockers.
Betaxolol is used to treat raised pressure of eye (intraocular pressure) which occurs in various conditions including glaucoma and ocular hypertension.
Before You Use Betaxolol
Do not use if you:
- are allergic (hypersensitive) to betaxolol hydrochloride or beta-blockers or to any other ingredient of this medicine (see section 6. for more details)
- suffer from a condition known as heart block, which causes your heart to beat at an abnormally slow rate
- suffer from cardiac failure, a condition where your heart cannot work normally
Take special care with Betaxolol
Before you use Betaxolol please tell your doctor if you:
- are taking beta-blocking agents or calcium antagonists by mouth or as eye drops
- are suffering from muscle weakness, condition called myasthenia gravis
- are suffering from diabetes or have problem with your thyroid gland
- are treated for pulmonary conditions such as asthma
Taking other medicines
Check with your doctor before using the eye drops if you are taking or using any other medicines, in particular:
- a calcium antagonist (e.g. verapamil or diltiazem) often used to treat high blood pressure, angina, or an abnormal heartbeat
- digoxin, often used to treat heart failure or an abnormal heartbeat
- medicines known as a catecholamine-depleting agents (e.g. rauwolfia alkaloids/ reserpine) used to treat high blood pressure
- a pressor amine (e.g. adrenaline) used to treat severe allergic reaction
- clonidine to treat high blood pressure
- quinidine, a medicine often used to treat abnormal heartbeat
- other beta-blockers (e.g. other preparations of Betaxolol both oral and/or ocular), which belong to the same group of medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without any prescription.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicines.
Betaxolol should not be used during pregnancy and breast-feeding unless considered essential by your doctor.
Driving and using machines
No effects on ability to drive and use machines have been reported. However do not drive or operate machines if you experience any visual disturbance or dizziness after using the product. Wait until this clears before driving or using machines.
Important information about some of the ingredients of Betaxolol Eye Drops:
The eye drops contain benzalkonium chloride as preservative which may cause eye irritation. Avoid contact with soft contact lenses. Remove contact lenses before using the eye drops and wait at least 15 minutes before reinserting. The preservative is known to discolour soft contact lenses.
How To Use Betaxolol
Always use Betaxolol exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The usual dose is one drop into each affected eye(s) twice daily, approximately 12 hours apart. If you are using in combination with another eye drop medicine, wait 5-15 minutes before applying the second eye drop.
Use in children:
It is not recommended to use Betaxolol in children.
Instructions for use:
(please also refer to pictograms at the end of the leaflet)
- First wash your hands
- Avoid touching the eye (or any other surface) with the tip of the bottle
- If you wear soft contact lenses, they should be removed before using the eye drops and wait at least 15 minutes before reinserting
- These drops are supplied as a sealed bottle with a spiked cap. When using the bottle for the first time, screw the cap down tightly in order to pierce the tip of the bottle
- Tilt your head back and look at the ceiling
- Pull the lower eyelid gently downwards
- Hold the bottle upside down above the eye and gently squeeze the bottle to release a drop into your eye
- Keep the affected eye closed and press your fingertip against the inside corner of the closed eye, and hold for 1 minute
- Repeat for the other eye if necessary
- Replace and tighten the cap immediately after use.
Be careful not to touch the tip of the bottle on your eye or on any other surface.
Ocular solutions, if handled wrongly, can become contaminated by common bacteria and cause eye infections. If you do develop any other eye condition whilst using this product, see your doctor immediately.
Keep using your medicine until your doctor tells you to stop.
If you use more Betaxolol than you should
If you accidentally use too much, contact your doctor or go to the nearest hospital casualty department immediately.
Overdose
There is no experience of an overdosage with Betaxolol which is unlikely when given as eyedrops. The signs of overdosage include slow heart rate, drop of blood pressure, breathing difficulties, and heart attack.
If you forget to use Betaxolol
Apply the drops as soon as you remember. However, if it is almost time for your next dose, do not double your dose and carry on with the normal schedule dose.
Possible Side Effects
Like all medicines, Betaxolol can cause side effects, although not everybody gets them.
If you experience a rare (these may affect between 1 in 1,000 and 1 in 10,000 patients) but serious allergic reaction (difficulty breathing, closing of the throat, swelling of the lips, tongue, or face or hives) to betaxolol, stop using the medication and contact your doctor immediately.
Rare possible side effects: (these may affect between 1 in 1,000 and 1 in 10,000 patients)
- changes to the surface of the eye, swollen or red eyelid, abnormal vision, sticky, weepy or watery eyes, sensitivity to light, irritation, pain, whitening of the membrane covering the inside of the eyelid/white of the eye
- low blood pressure, slowing of heart rate, heart failure, heart block, coldness or blue hands, feet and extremities, worsening of leg pain when exercising
- nausea, vomiting, diarrhoea
- headache, tiredness, dizziness, a tingling feeling in the hands and feet
- sleeplessness, nightmares, depression, confusion or any other psychiatric disturbance
- impotence
- difficulty breathing or worsening of asthma
- skin rashes, loss of hair
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How To Store Betaxolol
Keep out of the reach and sight of children.
Do not store at a temperature above 30°C.
Discard the bottle 28 days after opening, even if there is solution remaining.
Do not use Betaxolol after the expiry date which is stated on the bottle and on the carton the bottle is packed in.
Further Information
What Betaxolol contains
The active ingredient is betaxolol, where 5mg/ml betaxolol is equivalent to 5.6mg/ml of betaxolol hydrochloride. This product also contains disodium edetate, sodium chloride, benzalkonium chloride (as preservative) 0.01 % w/v and water for injection.
What Betaxolol look like and contents of the pack
One bottle of Betaxolol contains 5 ml solution.
Your medicine is a clear colourless, sterile solution.
Marketing Authorisation Holder and Manufacturer
Hampshire
PL number: 15872/0007
Hard to see or read the leaflet? Call+ 44(0) 1489 565222 for help.
This leaflet was last approved in: 02/2010
MODE OF USE
Tighten the cap on the nozzle till the cap touches the shouder.
The spike in the cap will pierce the tip of the bottle.
Tilt head backwards. Dispense drops with gentle pressure. Do not touch dropper tip to the surface of the eye.
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